Evidence map›Paper›PMID 33905264›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

National Marrow Donor Program-Sponsored Multicenter, Phase II Trial of HLA-Mismatched Unrelated Donor Bone Marrow Transplantation Using Post-Transplant Cyclophosphamide.

Bronwen E Shaw, Antonio Martin Jimenez-Jimenez, Linda J Burns, Brent R Logan, Farhad Khimani, Brian C Shaffer, Nirav N Shah, Alisha Mussetter, Xiao-Ying Tang, John M McCarty and 19 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 130 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed, 4 pooled it
21.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

130 citing papers in PubMed, 4 syntheses or guidelines pooled it, 202 citations in OpenAlex.

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70 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 13 institutions in 1 country.

Bronwen E ShawCenter for International Blood and Marrow Transplant Research/Medical College of Wisconsin, Milwaukee, WI.ORCID 0000-0003-3317-1896
Antonio Martin Jimenez-JimenezSylvester Comprehensive Cancer Center, University of Miami, Miami, FL.
Linda J BurnsCenter for International Blood and Marrow Transplant Research/Medical College of Wisconsin, Milwaukee, WI.ORCID 0000-0003-1341-4424
Brent R LoganCenter for International Blood and Marrow Transplant Research/Medical College of Wisconsin, Milwaukee, WI.ORCID 0000-0002-4473-4044
Farhad KhimaniH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Brian C ShafferAdult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Nirav N ShahDepartment of Medicine, Medical College of Wisconsin, Milwaukee, WI.ORCID 0000-0002-4336-1071
Alisha MussetterCenter for International Blood and Marrow Transplant Research/National Marrow Donor Program, Minneapolis, MN.
Xiao-Ying TangCenter for International Blood and Marrow Transplant Research/Medical College of Wisconsin, Milwaukee, WI.ORCID 0000-0002-8097-0298
John M McCartyMassey Cancer Center Bone Marrow Transplant Program, Virginia Commonwealth University, Richmond, VA.
Asif AlaviDepartment of Oncology, Blood and Marrow Stem Cell Transplant Program, Karmanos Cancer Institute/Wayne State University, Detroit, MI.
Nosha FarhadfarDivision of Hematology/Oncology, University of Florida College of Medicine, Gainesville, FL.
Katarzyna JamiesonUniversity of North Carolina Hospitals - Chapel Hill, Chapel Hill, NC.
Nancy M HardyGreenebaum Cancer Center, University of Maryland, Baltimore, MD.ORCID 0000-0002-6054-6836
Hannah ChoeJames Comprehensive Cancer Center, The Ohio State University Wexner Medical Center, Columbus, OH.
Richard F AmbinderThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Claudio AnasettiH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Miguel-Angel PeralesAdult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-5910-4571
Stephen R SpellmanCenter for International Blood and Marrow Transplant Research/National Marrow Donor Program, Minneapolis, MN.ORCID 0000-0002-7271-8252
Alan HowardCenter for International Blood and Marrow Transplant Research/National Marrow Donor Program, Minneapolis, MN.
Krishna V KomanduriSylvester Comprehensive Cancer Center, University of Miami, Miami, FL.ORCID 0000-0003-3715-5236
Leo LuznikThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Maxim NorkinLifeSouth Community Blood Centers, Baptist MD Anderson Cancer Center, Jacksonville, FL.
Joseph A PidalaH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Voravit RatanatharathornDepartment of Oncology, Blood and Marrow Stem Cell Transplant Program, Karmanos Cancer Institute/Wayne State University, Detroit, MI.
Dennis L ConferCenter for International Blood and Marrow Transplant Research/National Marrow Donor Program, Minneapolis, MN.
Steven M DevineCenter for International Blood and Marrow Transplant Research/National Marrow Donor Program, Minneapolis, MN.ORCID 0000-0001-7731-759X
Mary M HorowitzCenter for International Blood and Marrow Transplant Research/Medical College of Wisconsin, Milwaukee, WI.ORCID 0000-0002-9502-785X
Javier Bolaños-MeadeThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Medical College of Wisconsin · USNational Marrow Donor Program · USMoffitt Cancer Center · USSidney Kimmel Comprehensive Cancer Center · USMemorial Sloan Kettering Cancer Center · USUniversity of Miami · USWayne State University · USBaptist Cancer Center · USThe Ohio State University Wexner Medical Center · USUniversity of Florida · USUniversity of Maryland, Baltimore · USUniversity of North Carolina Hospitals · USVirginia Commonwealth University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Data Resource for Analyzing Blood &Marrow TransplantsU24CA076518 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI Amy M Moskop, Bronwen Shaw · 1998 to 2026
$105.2M
NCI NIH HHS P30 CA008748NCI NIH HHS U24 CA076518
6 · The paper itself

Abstract

purposeHematopoietic cell transplantation (HCT) is curative for hematologic disorders, but outcomes are historically inferior when using HLA-mismatched donors. Despite unrelated donor registries listing > 38 million volunteers, 25%-80% of US patients lack an HLA-matched unrelated donor, with significant disparity across ethnic groups. We hypothesized that HCT with a mismatched unrelated donor (MMUD) using post-transplant cyclophosphamide (PTCy), a novel strategy successful in overcoming genetic disparity using mismatched related donors, would be feasible and increase access to HCT. PATIENTS AND

methodsWe performed a prospective phase II study of MMUD bone marrow HCT with PTCy for patients with hematologic malignancies. The primary end point was 1-year overall survival (OS), hypothesized to be 65% or better. 80 patients enrolled at 11 US transplant centers (December 2016-March 2019). Following myeloablative or reduced-intensity conditioning-based HCT, patients received PTCy on days +3, +4, with sirolimus and mycophenolate mofetil starting on day +5. We compared outcomes to Center for International Blood and Marrow Transplant Research contemporary controls receiving PTCy.

resultsNotably, 48% of patients enrolled were ethnic minorities. 39% of pairs were matched for 4-6 out of 8 HLA alleles. The primary end point was met, with 1-year OS of 76% (90% CI, 67.3 to 83.3) in the entire cohort, and 72% and 79% in the myeloablative and reduced-intensity conditioning strata, respectively. Secondary end points related to engraftment and graft-versus-host-disease were reached. Multivariate analysis comparing the study group with other mismatched HCT controls found no significant differences in OS.

conclusionOur prospective study demonstrates the feasibility and effectiveness of HCT with an MMUD in the setting of PTCy. Remarkably, nearly half of the study participants belonged to an ethnic minority population, suggesting this approach may significantly expand access to HCT.

Indexed as

Unrelated DonorsAdolescentAdultAgedCyclophosphamideFemaleGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHumansLeukemiaLymphomaMaleMedically Underserved AreaMiddle AgedMinority GroupsMyelodysplastic SyndromesCyclophosphamide

Identifiers

PMID33905264
PMCPMC8260905
OpenAlexW3159907345

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.